This is a blog by a former CEO of a large Boston hospital to share thoughts about hospitals, medicine, and health care issues.

Thursday, May 06, 2010

A painful story

This is a painful story to write.

A close friend of mine, in his 40's, had a persistent light cough for many months. Finally, when he had an X-ray taken, it showed a large tumor on his lungs. He was diagnosed with stage 4 lung cancer. As a non-smoker and strapping, physically fit man, he was shocked, as you can imagine.

He went to his non-Boston-based medical practice, and he was told the prognosis was 12 to 18 months before he would die. They offered him, though, the chance to enroll in a clinical trial, based on a cocktail of chemotherapy agents.

Meanwhile, he wrote to me and another hospital-based friend in Boston, and our cancer experts in both places pointed out that there is a particular genotype of tumor that is susceptible to an oral chemotherapy drug. This type of tumor is present, in the case of non-smokers, about 17% of the time. Folks here recommended that he have a biopsy to see if he was "lucky."

When he went back to his local medical practice and relayed this information from two of the world's greatest oncologists, the local doctor discouraged him from getting the biopsy. He said that recovery from the biopsy operation would delay the start of the clinical trial by a month. The doctor intimated that there were very few slots left in the trial and that my friend might be excluded if he waited.

My friend chose to ignore the local doctor's recommendation, relying on the advice of the Boston doctors. He came here and had the biopsy. It was a match. He started the chemotherapy regime, and it shrunk the tumor by 90%. This enabled it to be surgically removed, with good pathology results in the surrounding tissues. After surgery, he returned home in good shape and has started a maintenance chemotherapy program.

Upon returning home, too, he discovered that the local clinical trial actually was not at all fully subscribed, that they have been having trouble getting enough subjects.

The conclusions I draw from this are very distasteful. Perhaps I am too close to this because it involved a friend, and perhaps others of you see this differently; but I see a medical practice that intentionally put one its patients at risk to support the professional advancement of one of its doctors, and perhaps the financial advancement of that person or the practice, too.

34 comments:

To answer your question, no. This is a major concern within medicine. Where is the communication between facilities? Where is the transparency in clinical trials? Where is the database with comparative research to help such patients make these very hard decisions. Thank you for writing this post. This sheds more light on a frequent problem.

First, congratulations to your friend. He is an example of major advances in basic research and therefore personalized medicine which were not even imagined when I trained in the late '70's.As for your conclusion, my clinical colleagues would know better than me,but my initial reaction is, 'not enough information.' Inferring malign motivation from the fact the clinical trial turned out not fully subscribed, which could have been for unexpected reasons, may be premature. I look forward to clinicians' reactions.

For me what was also striking about this situation is how lucky he was to have friends in the medical field with whom he could consult...we are clearly NOT all treated equally when it comes to medical care and knowing the right people, in this case, may have saved his life. what happens to people who don´t know people???

To me this is not even a small step away, it's a half-step away, from the silence that keeps in place the accidental "killing and maiming" that you cited in your speech to the hospitalists. IMO this should be reported to the hospital's ethics board, because it's extremely likely that other patients are being told the same.

The hospital should interview the few patients who are already enrolled in the study.

It is unfortunate and distasteful and all the things you're characterizing it as. The only fact I would add is that there are several situations where the tables are turned and a "Boston medical center" is pulling such tactics which a referral to a "non-Boston medical center" resolves. I'm all for the solutions described above to limit the problem all around.

I don't think you were too harsh at all. As an MD/PhD student we have discussed issues like this. I don't think it ethical for a physician to recruit his own patients to a clinical trial from which he will benefit. That would be like a physician choosing to prescribe one medication over another because he sits on the advisory board for the pharmaceutical company that makes it.

No, you are not unfair. Unfortunately, this is not a unique case. The extremely competitive environment of cancer research, the financial “pressure” from drug companies and hospitals has caused this type of deviation in treatment. Among others this is one of the biggest reasons why second and third opinion is highly recommended in every tumor diagnosis.

I think this is an example of a larger problem in medicine, where subtle (and not-so-subtle) coercion is used to get patients to consent.

If a clinician gets a benefit based on the number of patients that sign up for a clinical trial, or have surgery, there is no way that person can be completely unbiased. The clinician needs to at least be aware of this when talking to patients.

I think I side with the "not enough information" group. The doctors in the first hospital may NOT have known the status of that first trial. I certainly hope this is the case. If not . . . ugh!

However, I am also a firm believer in taking ownership of one's own health . . . True, knowing the right people is a factor here, but so is the decision to seek other opinions and make an informed decision.

I have a brilliant family doc who takes the stance that the patient is the responsible individual here and that he or she needs the best information to make that informed decision. I believe that all too often people rely TOO HEAVILY on the judgement of one person, be it a doctor or a home remodeling service.

I was also going to post that it's a good example of why people should get second opinions. It's possible that the doctor thought he was doing his patient a favor by enrolling him in the trial (though there is that little inconvenient lie about the trial being nearly full). In my opinion, his big mistake was not sending the patient to a specialist - for not suggesting a second opinion himself. Whether because of greed or lack of knowledge, the doc was clearly in over his head and didn't even know it.

This is an ugly story with a great outcome. I hope your friend continues to thrive for a long time.

You are in no way unfair in your characterization. I see more than a few clinicians put their research goals ahead of the patient and the organization that supports them. It is unfortunate and as your title says, painful.

Nancy: This is almost like the story of who gets convicted and who doesn't. If you have enough resources your outcome will be very different from those who don't. I think we ALL agree that his VERY well known local cancer center was only looking out for themselves and if he had a death sentence it didn't matter.

Ann: This is unreal, almost like reading a Stephen King novel.

Kasey: As someone working in cancer clinical trials (at BIDMC) I know it can be tough to enroll and find patients willing to take "cocktails of chemotherapy agents" as you put it. But when thinking about clinical trials for patients you *always* have to think about what's best for the patient. That's what I love about working with oncologists here.

I hate to think that this non-Boston medical practice wasn't putting the patient first, but that's the way it sounds.

Thomas: We had a very similar story with my Dad. Our local doc said there was no reason to see any one else and that the trial we investigated was closed. We ended up going to Boston where he received extraordinary treatment, enrolled in the trial (which was still open), and was given at least a shot at life. The local doctor had just written him off. So sad to [hear] these stories.

This certainly sounds like questionable behavior from the local doc, though to be fair, that particular site may have been near to full enrollment, while the overall trial may still have been under-enrolled. When approving clinical trials, the FDA places strict limits on enrollment (by site), and any deviation can result in a trial being shut down.

Another factor to consider is the large burden places on clinical sites due to, in many cases, almost unreasonable enrollment criteria. I've seen a number of trials nearly sunk by either poor planning by the trial sponsor or unnecessary restrictions placed on enrollment by the FDA (such as prior procedures and existing conditions), resulting in investigators struggling to enroll any patients at all. This in no way excuses the reckless behavior of the local doctor, but should be considered as a potential source of such conflict. By reducing the instance of difficult-to-satisfy enrollment criteria (either by sponsor mismanagement or FDA heavy-handedness), the temptation for doctors to engage in such behavior is minimized.

No, you are not being unfair. Of course it is not illegal for an MD to encourage his patient to enter a study but the failure to be open, and the use of coercion is not just unethical, it is illegal.

If I were this patient, I would report this episode to the sponsor of the study so that this physician can be watched closely or be removed as an investigator. I suspect that this episode is neither the first nor the only instance of this behavior and reporting this is a step toward protecting other patients when in their most vulnerable state.

The only real problem may be in the apparent discrepancy between "very few slots left" and "not at all fully subscribed", but both are qualitative estimates. If the trial was, say, 75% full, both statements apply.

All the rest is just emotions guided by the outcome. After reading your stirring description people tend to forget that apriori there was about 10-15% chance for this lucky outcome.

Another (not at all remote) possibility would be that your friend comes to Boston, has his biopsy, discovers that he is out of luck, goes home, waits for a month, qualifies for the trial after a major hassle, sees some improvement in his condition and then dies, since he started therapy too late. His family hates you for the rest of your life.

Unfortunately this is not a Stephen King novel, this is very much reality, which can happen anywhere. The problem is usually that people don’t believe this until they see one personally.

I don’t know which is worse for a doctor, greed or lack of knowledge…

To know the right people or rather to be lucky enough to know the right people is one of the most important factors. But also the courage to go further seeking the best individual treatment option is an invaluable personal resource in such cases. Support groups are great help in this.

Please know that I offered no medical advice in this situation. I am not a doctor.

From what I was told, the advice he received from the Boston doctors was that the biopsy was well worth the calculated risk. If it was not the right tumor, the delay in his particular case would be unlikely to make a difference in his prognosis.

They also would have disagreed with you about the 10-15% chance of success with the "lucky" genotype -- but I am not qualified to question either you or them on that point.

Sorry, I've missed another one -- if they did not inform him at all (did they?) that there was an option of biopsy to check his genotype, that's probably malpractice or close to it.

Still, there is a fair chance that "intentionally put one its patients at risk" is an overstatement -- they may believe in their approach, and they might even be right about it, nobody knows yet, of course.

The 10-15% is just taking your 17% figure of the "lucky" genotype and then being very optimistic about the success of the treatment itself -- I was talking about overall chances before biopsy results.

Oh, and people's hatred can be wonderfully misdirected -- you don't need me to tell you that.

The variability in medical practice from one MD to the other is very real and like e-Patient Dave says is why you should always get a second opinion. I have heard countless stories from friends and colleagues that are similiar to the one that Paul described in this post. And it doesn't have to be a life threatening situation either for a second opinion. Sometimes a different techinque or a different philosophy can have a huge impact on how quickly you recover from surgery or how effectively your pain is managed. Doctors are good, smart people with all the best intentions but they are human and as such, bring their biases to the exam room too.

I am sorry for your friend and for you. Hopefully your friend will have many good and full days and will suffer as little as is possible.

Your narrative does make it appear that there was a violation of informed consent. There are federal regulations that address this (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116)and the consent, as presented, seems to have "missed the mark" : "(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject". It is better to look at the cup as half full.

Derrrrr - are you truly being naive? As someone who has worked the hospital op trenches for my entire career, I've seen the good, the bad and the ugly. The hospital industry has 8 million stories like this - this is just one of them.

As a member of the clinical research community here at BIDMC, stories like these remind me of why we have our safety mechanisms in place every step of the way, from the astute nurses at the Clinical Research Center to the assiduous members at our Institutional Review Board. No wonder our hospital is regarded as a top research hospital!

This hits close to home for me. While I am not a cancer patient, I have a rare disease that is both disabling and potentially life threatening. Because every doctor who specializes in this disease is also a "researcher," my odyssey of seeking treatment has been filled with doctors demanding, directly or not, that I be a data source for whatever study they are doing as a condition of treatment -- and that treatment recommendations are driven more by having "pure" research than what is best for me. One longs for a honest broker. It makes what should be a cooperative relationship in a very difficult situation an adversarial one. Bottom line, there is a conflict of interest in being both a personal physician and being a researcher.

The sad truth, from my perspective is that the drive for "pure" research has killed much of what is true learning in the medical profession. Researchers look for hard lab results, and meeting of algorithms, to prove a point. Doctors listen to symptoms to find a solution -- and what is a good solution is inherently subjectively defined - from the patient's perspective, not the doctor's. And finding that solution takes listening, communicating well and strong analytic skills.

What that doctor did was wrong. The patient had a right to understand his options, even if some of those options are not what the doctor in questions would have recommended. The doctor certainly had the obligation not to use high pressure sales techniques -- both legally and morally.

The funny thing about second opinions -- people choose the one they want to hear. Physcians are human - who knows what to believe? How would any person know which path to take? We are told leading academic centers know all, but there are plenty of great docs at community hospitals.

Our rabbis teach us to always assume best intentions. Have you talked directly to the doctor who allegedly gave the inaccurate assessment? Did he offer any explanation? Does he need further education about biopsy recovery times and where to look up or call for the status of the clinical trial's accrual? What exactly what his motivation -- from his POV?

One should also consider that studies have shown that cancer patients retain less than 20% of what is told them at initial consultations, and often that is mis-remembered.

So, yes, I think you were harsh in assuming the worst possible explanation (financial gain) is the answer here. And even if the problem is simply an undereducated physician, you've missed the opportunity to educate the doctor and hopefully prevent such misguided advice again.